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Improving Quality of Life for Veterans Undergoing Interferon Treatment

US Department of Veterans Affairs (VA) logo

US Department of Veterans Affairs (VA)

Status

Completed

Conditions

Hepatitis C
Depression

Treatments

Behavioral: Telehealth Treatment

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00117559
F3332-P

Details and patient eligibility

About

The purpose of this study is to evaluate a group psychotherapy intervention and a telehealth intervention for veterans undergoing interferon treatment for the hepatitis C virus. It is hypothesized that the cognitive behavioral therapy (CBT) condition and the telehealth condition will result in significantly improved outcomes, including enhanced adherence, quality of life, and psychological status.

Full description

The purpose of the proposed pilot study is to evaluate a rehabilitative cognitive-behavioral group psychotherapy intervention and a telehealth intervention for veterans undergoing interferon treatment for the hepatitis C virus (HCV). The specific objectives of the proposed pilot study are: 1) develop study methods and materials; 2) evaluate study feasibility; and 3) assess the efficacy of a cognitive-behavioral group therapy approach and a telehealth approach as compared to care as usual in a randomized design. Participants will be 45 patients (15 participants in each condition) from the VA Boston Healthcare System who are undergoing interferon treatment for HCV. Assessment will occur at pre-treatment, post-treatment, and 3-month follow-up. Assessments will measure key areas, including adherence, quality of life, and psychological distress. Analyses will examine study feasibility and the effects of the treatment condition. It is hypothesized that the CBT condition and the telehealth condition will result in significantly improved outcomes, including enhanced adherence, quality of life, and psychological status. This treatment approach addresses initiatives by the National VHA Hepatitis C Program by optimizing the care of veterans experiencing the devastating side effects of interferon treatment.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Clinical diagnosis of hepatitis C.
  • Must be on the interferon treatment
  • Need to have access to telephone.

Exclusion criteria

  • Life threatening or acute illness
  • Current alcohol or substance abuse or dependence
  • Individuals already receiving psychological interventions specifically to manage the side effects of the IFN treatment.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

19 participants in 2 patient groups

TEL-CBT
Experimental group
Description:
Telehealth, problem solving based treatment provided over the telephone
Treatment:
Behavioral: Telehealth Treatment
Treatment as Ususal
No Intervention group
Description:
Control group, no treatment provided

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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